Quality of Life Among Children With Congenital Heart Disease

Congenital Heart Disease Clinical Trial

Official title:

Quality of Life Among Children With Congenital Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01202916
• Other study ID #: 8422
• Status: Completed
• Start date: September 2009
• Est. completion date: September 2011

Study information

• Verified date: March 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Congenital heart diseases (CHD) are the first cause of congenital malformations with an incidence of 8 for 1000 births. Within the two past decades prenatal diagnosis has had a great impact on CHD prevalence. France was the first country to show the impact of prenatal diagnosis on the lowering prevalence of the most severe CHD, the hypoplastic left heart syndrome. Since the 90's, great advances in pediatric cardiac surgery, intensive care and cardiac catheterization have led to lower mortality and morbidity in this population. Prevalence of " GUCH ", grown-ups with congenital heart disease has thus been significantly increasing. For all these reasons and as the investigators can also see in other many chronic diseases, new questions about the quality of life of these patients arise among patients, parents/future parents, doctors, patients associations, and public health organizations. In 2007 French government promoted a national public health plan for "improvement of the quality of life among patients suffering from chronic illnesses". First step of such a program is to correctly evaluate this quality of life. Indeed the concept of "quality of life" (QoL) remains subjective and difficult to appreciate and measure. Its analysis requires the use of validated questionnaires. Few questionnaires are available in Europe, especially in pediatrics. Few studies in this population have been led and no comparative study to a control randomized group has been published. The investigators study aims to analyze in the investigators tertiary care center in pediatric cardiology the QoL among 8 to 18 year old French patients with CHD using a validated questionnaire (Kidscreen™) and to compare it to same aged healthy children. The investigators secondarily intend to :- validate the French version of one reference pediatric QoL questionnaire used in most publications in the USA (PedsQL™). - compare the QoL to the severity of the CHD using a published semi-quantitative score.- compare the QoL to the severity of the CHD using the results of routine exercise tests (VO2 max) performed routinely in the investigators center. The investigators hypothesis are that :- Quality of life of most common and not severe CHD is close to that of healthy children. - QoL of severe CHD is not so well correlated to severity of CHD.- PedsQL™ is a simple questionnaire which can be used in France in routine follow-up of children with CHD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 316
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

• patients with congenital heart disease (defined by Chapter Q of the ICD-10)

• Patient participation in the study noted in the medical record.Exclusion Criteria:

• Age greater than or equal to 8 years and less than 18 years

• Whose parents signed written consent

• Obligation of membership or beneficiary of a French social security

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Locations

Country	Name	City	State
France	Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

References & Publications (8)

Abassi H, Gavotto A, Picot MC, Bertet H, Matecki S, Guillaumont S, Moniotte S, Auquier P, Moreau J, Amedro P. Impaired pulmonary function and its association with clinical outcomes, exercise capacity and quality of life in children with congenital heart d — View Citation

Amedro P, Bajolle F, Bertet H, Cheurfi R, Lasne D, Nogue E, Auquier P, Picot MC, Bonnet D. Quality of life in children participating in a non-selective INR self-monitoring VKA-education programme. Arch Cardiovasc Dis. 2018 Mar;111(3):180-188. doi: 10.1016/j.acvd.2017.05.013. Epub 2017 Nov 1. — View Citation

Amedro P, Dorka R, Moniotte S, Guillaumont S, Fraisse A, Kreitmann B, Borm B, Bertet H, Barrea C, Ovaert C, Sluysmans T, De La Villeon G, Vincenti M, Voisin M, Auquier P, Picot MC. Quality of Life of Children with Congenital Heart Diseases: A Multicenter — View Citation

Amedro P, Gavotto A, Guillaumont S, Bertet H, Vincenti M, De La Villeon G, Bredy C, Acar P, Ovaert C, Picot MC, Matecki S. Cardiopulmonary fitness in children with congenital heart diseases versus healthy children. Heart. 2018 Jun;104(12):1026-1036. doi: — View Citation

Amedro P, Huguet H, Macioce V, Dorka R, Auer A, Guillaumont S, Auquier P, Abassi H, Picot MC. Psychometric validation of the French self and proxy versions of the PedsQL™ 4.0 generic health-related quality of life questionnaire for 8-12 year-old children. — View Citation

Amedro P, Tahhan N, Bertet H, Jeandel C, Guillaumont S, Mura T, Picot MC. Health-related quality of life among children with Turner syndrome: controlled cross-sectional study. J Pediatr Endocrinol Metab. 2017 Aug 28;30(8):863-868. doi: 10.1515/jpem-2017-0026. — View Citation

Gavotto A, Huguet H, Picot MC, Guillaumont S, Matecki S, Amedro P. The V?e/V?co(2) slope: a useful tool to evaluate the physiological status of children with congenital heart disease. J Appl Physiol (1985). 2020 Nov 1;129(5):1102-1110. doi: 10.1152/japplp — View Citation

Gavotto A, Vandenberghe D, Abassi H, Huguet H, Macioce V, Picot MC, Guillaumont S, Matecki S, Amedro P. Oxygen uptake efficiency slope: a reliable surrogate parameter for exercise capacity in healthy and cardiac children? Arch Dis Child. 2020 Dec;105(12): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life questionnaire		one day